Regulatory Affairs Specialist – Medical Devices

Abbott; Pleasanton (CA); On-site; USD 74,000 - 116,000; Full time

Benefits offered by this job

Free HIP PPO medical plan next year

Excellent retirement savings with high

Tuition reimbursement

FreeU education benefit

Job summary

Abbott is seeking a Regulatory Affairs Specialist for the Pleasanton, CA area to support the Heart Failure division. As an individual contributor, you will assist regulatory submissions, manage documentation, and liaise across functions to maintain approvals and licensing for medical devices.

You will interact with regulatory agencies, ensure compliance with FDA and global requirements, and contribute to timely product registrations while supporting quality systems and EMS within a matrixed,

Qualifications

• Bachelor’s Degree or equivalent in a technical discipline.
• No experience or some experience in medical device industry.
• Ability to work in a matrixed, fast-paced environment and communicate across levels.

Responsibilities

• Submit product registrations and manage regulatory submissions.
• Collaborate with cross-functional teams to support product licensing and documentation.
• Support product release by processing licenses and release requests.
• Serve as regulatory liaison throughout product lifecycle.
• Ensure timely approvals of medical devices and continued product approvals.

Skills

Regulatory affairs knowledge

Strong verbal and written comms

Cross-functional collaboration

Attention to detail

Education

Bachelor's Degree in technical discipline or equivalent

Master’s Degree in science/engineering preferred

Job description

Abbott is seeking a Regulatory Affairs Specialist for the Pleasanton, CA area to support the Heart Failure division. As an individual contributor, you will assist regulatory submissions, manage documentation, and liaise across functions to maintain approvals and licensing for medical devices.

You will interact with regulatory agencies, ensure compliance with FDA and global requirements, and contribute to timely product registrations while supporting quality systems and EMS within a matrixed,